Cosmetic claims in the EU: what you may say about a cosmetic and the proof you must hold

A cosmetic claim is any statement, name, picture or sign that tells the buyer what a cosmetic is or does. The EU Cosmetics Regulation, Regulation (EC) No 1223/2009Regulation (EC) No 1223/2009, Cosmetic Products RegulationThe whole regulationClick opens the law on the EU Publications Office., forbids a claim that implies a characteristic or function the product does not have (Art. 20(1)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 20, paragraph 1Click opens the article on EUR-Lex.). Commission Regulation (EU) No 655/2013Commission Regulation (EU) No 655/2013, common criteria for cosmetic product claimsThe whole regulationClick opens the law on the EU Publications Office. sets six criteria every claim must meet.

What counts as a claim

“In the labelling, making available on the market and advertising of cosmetic products, text, names, trade marks, pictures and figurative or other signs shall not be used to imply that these products have characteristics or functions which they do not have” (Art. 20(1)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 20, paragraph 1Click opens the article on EUR-Lex.). Regulation (EU) No 655/2013Commission Regulation (EU) No 655/2013, common criteria for cosmetic product claimsThe whole regulationClick opens the law on the EU Publications Office. spells out the reach: texts, names, trade marks, pictures and figurative or other signs that convey product characteristics or functions “explicitly or implicitly”, in the labelling, the making available on the market and the advertising. It covers “any claim, irrespective of the medium or type of marketing tool used, the product functions claimed, and the target audience” (Art. 1Commission Regulation (EU) No 655/2013, common criteria for cosmetic product claimsArticle 1Click opens the article on EUR-Lex. of Regulation (EU) No 655/2013). A marketplace listing is making available and advertising, so its title, bullet points, images and any extra product content are claims when they say or show what the product does. A product for professionals is covered as well, since an end user is a consumer or a professional (Art. 2(1)(f)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 2, paragraph 1, point (f)Click opens the article on EUR-Lex.).

Regulation 655/2013 applies from 11 July 2013 and is binding in its entirety and directly applicable in every EU country (Art. 3Commission Regulation (EU) No 655/2013, common criteria for cosmetic product claimsArticle 3Click opens the article on EUR-Lex. of Regulation (EU) No 655/2013). It does not list approved or banned words. It says the common criteria “should not aim at defining and specifying the wording that can be used” (Recital 7), so a claim passes or fails on the message it conveys. The criteria also apply without prejudice to the Unfair Commercial Practices Directive, the Directive on misleading and comparative advertising and other Union law (Recital 5).

The responsible person ensures that the wording of each claim meets the criteria and is consistent with the documentation proving the effect claimed in the product information file (Art. 2Commission Regulation (EU) No 655/2013, common criteria for cosmetic product claimsArticle 2Click opens the article on EUR-Lex. of Regulation (EU) No 655/2013). Claims are among the duties the Cosmetics Regulation gives that person (Art. 5(1)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 5, paragraph 1Click opens the article on EUR-Lex.). The authority judges a claim by the “average end user”, who is “reasonably well-informed and reasonably observant and circumspect”, taking account of social, cultural and linguistic factors in the market in question (Annex, point 1(2)).

What binds you and what only guides

The technical document is the version of 3 July 2017, and the Commission’s cosmetics legislation page lists that version on 5 October 2026. Its first page says that the Sub-Working Group on Claims prepared it, that the Working Group on Cosmetic Products endorsed it, that it “is not a European Commission document”, that its views “are not legally binding” and that it “remains a work in progress subject to modifications”. It calls itself a “tool” and “a collection of best practice”, and leaves it to national authorities and courts to assess, case by case, which claims are allowed. The annexes on “free from” and “hypoallergenic” were added on 3 July 2017 and were agreed to apply from 1 July 2019. The examples below are the document’s own; they show how authorities read the criteria and are not a list written in law.

The six criteria, with examples

The Annex to Regulation 655/2013 sets the criteria, and the technical document gives examples for each. They carry equal weight.

“Free from” claims

A claim that a product lacks an ingredient is a claim like any other. The technical document adds guidance for it in Annex III, because the criteria alone do not protect buyers enough against misleading “free from” claims. The examples are the document’s own.

The document also says the absence of an ingredient is shown by adequate and verifiable evidence (Annex III, evidential support). Neither Regulation (EC) No 1223/2009Regulation (EC) No 1223/2009, Cosmetic Products RegulationThe whole regulationClick opens the law on the EU Publications Office. nor Regulation 655/2013 contains a “free from” rule of its own.

The “hypoallergenic” claim

Annex IV of the technical document gives “hypoallergenic” its own test. The claim “can only be used in cases, where the cosmetic product has been designed to minimize its allergenic potential”.

• Evidence. The responsible person has data that verify and confirm a very low allergenic potential through “scientifically robust and statistically reliable data”, for example post-marketing surveillance data, and keeps that assessment up to date.
• No known allergens. The presence of known allergens or allergen precursors “should be totally avoided”: substances identified as sensitizers by the Scientific Committee on Consumer Safety (SCCS) or its predecessors, or by other official risk assessment committees; skin sensitizers of category 1, 1A or 1B under the CLP Regulation; substances identified from the company’s consumer complaints; substances generally recognised as sensitizers in the scientific literature; and substances for which data on sensitizing potential are missing.
• No guarantee. The claim does not guarantee a complete absence of the risk of an allergic reaction, and the product should not give that impression.
• Meaning to the buyer. The company should consider whether consumers in each country understand the word, and make clarification available if needed.

The fragrance allergens the label has to name are a separate duty, but they bear on this word. The labelled allergens are the ones the SCCS identified as having clearly caused allergies in humans (recital 6 of Regulation (EU) 2023/1545), and Annex IV asks for known allergens to be totally avoided, SCCS-identified sensitizers included. So if the product contains any listed fragrance allergen, at any level, leave the word “hypoallergenic” out.

“Tested” claims

Annex II of the technical document says what authorities expect behind four common claims:

The document adds that consumers expect such a claim only when the effects tested are favourable. For “dermatologically tested” it cites the Court of Justice (Case C-99/01): the average consumer expects tests of the product’s effects on the skin, with positive results and good tolerance.

Sun protection claims

The technical document refers to the Commission’s Recommendation 2006/647/EC on sunscreen claims. A Recommendation is not binding. It says no claim should imply 100% protection from UV radiation, such as “sunblock”, “sunblocker” or “total protection”, or that the product need not be re-applied under any circumstances, such as “all day prevention” (point 5). It says sunscreen products should display warnings that they do not give 100% protection (point 6).

The animal testing claim

The responsible person may say that no animal tests were carried out only if the manufacturer and its suppliers did not carry out or commission an animal test on the finished product, its prototype or any ingredient, and did not use ingredients that others tested on animals to develop new cosmetics (Art. 20(3)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 20, paragraph 3Click opens the article on EUR-Lex.). The claim may appear on the packaging or in any document, notice, label, ring or collar that accompanies or refers to the product. The rule on the ban itself, and the animal-test data the file holds, are in the EU Cosmetics Regulation guide.

The proof the product information file holds

Where the nature or the effect of the product justifies it, the product information file contains “proof of the effect claimed” (Art. 11(2)(d)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 11, paragraph 2, point (d)Click opens the article on EUR-Lex.). The responsible person keeps the file for ten years after the last batch is placed on the market, readily accessible at the address on the label, in a language the authority of that EU country easily understands (Art. 11(1)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 11, paragraph 1Click opens the article on EUR-Lex., Art. 11(3)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 11, paragraph 3Click opens the article on EUR-Lex.). The authority checks it in its in-market controls (Art. 22Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 22Click opens the article on EUR-Lex.), and the responsible person hands over the documents that show conformity on a reasoned request (Art. 5(3)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 5, paragraph 3Click opens the article on EUR-Lex.). The file is the same file as the one the cosmetic product safety report sits in.

The criteria and the technical document set what the evidence has to be:

• It is adequate and verifiable, whatever kind it is, including expert assessments where appropriate, and takes account of state of the art practice (Annex, point 3).
• A study relied on is relevant to the product and the benefit claimed, follows a well-designed, well-conducted method that is valid, reliable and reproducible, and respects ethical considerations (Annex, point 3).
• The level of evidence fits the claim. The acceptability of a claim rests on the weight of evidence of all the studies, data and information available (Annex, point 3).
• The responsible person determines the method and the evidence, justifies them in the file where necessary, and ensures the evidence still applies when the formula changes (technical document, Annex I). The authorities may evaluate whether the method and the evidence are appropriate and relevant.

A report for an experimental study or a consumer test identifies the product, so that the report links to the product on the market. It states the objective, the test schedule and protocol, the results and their interpretation and the statistics, and carries the signature of the person in charge of the study (Annex II).

Where a claim turns a cosmetic into a medicine, a medical device or a biocide

The six criteria apply only once the product is a cosmetic. It is for the national authorities and courts to decide, case by case, which regulatory framework applies (Recital 4 of Regulation 655/2013). A cosmetic product is a substance or mixture placed on the outside of the body or the teeth and mouth “exclusively or mainly” to clean, perfume, change the appearance of, protect, keep in good condition or correct the odour of those parts (Art. 2(1)(a)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 2, paragraph 1, point (a)Click opens the article on EUR-Lex.). The Commission can decide whether a product falls within the definition (Art. 2(4)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 2, paragraph 4Click opens the article on EUR-Lex.).

Medicine. A medicinal product is any substance “presented as having properties for treating or preventing disease in human beings”, or one that may be used to restore, correct or modify physiological functions by a pharmacological, immunological or metabolic action (Art. 1(2) of Directive 2001/83/EC). In a case of doubt, where a product may be both a medicine and a product under other Union legislation, the Directive applies (Art. 2(2) of Directive 2001/83/EC), and no medicinal product may be placed on the market without a marketing authorisation (Art. 6(1) of Directive 2001/83/EC). A product that is a medicine falls exclusively under the medicines framework. The presentation counts: the Borderline manual, version 5.5 of June 2025, quotes the Court of Justice that a product expressly indicated or recommended as having therapeutic or prophylactic properties is a medicine by virtue of its presentation, even if it has no known therapeutic effect (paragraphs 94 and 98). On hair products it adds that claims “may give a useful indication to the competent authorities, without, however, replacing a careful assessment of the mode of action” (paragraph 106).

Biocide. A biocidal product is a substance or mixture, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of or otherwise controlling a harmful organism by means other than mere physical or mechanical action (Art. 3(1)(a)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 3, paragraph 1, point (a)Click opens the article on EUR-Lex.). Subject to any explicit provision to the contrary, the Biocidal Products Regulation does not apply to products that fall within the Cosmetics Regulation, but where such a product is used for a purpose the Cosmetics Regulation does not cover, it applies to that purpose (Art. 2(2)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 2, paragraph 2Click opens the article on EUR-Lex.). Its product-type 1 covers products for human hygiene whose primary purpose is disinfecting the skin or scalp (Annex V). A biocidal product may not be made available unless authorised, apart from the national transition rule of Art. 89(2) for products whose active substances are still under examination (Art. 17(1)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 17, paragraph 1Click opens the article on EUR-Lex., Art. 89(2)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 89, paragraph 2Click opens the article on EUR-Lex.). The biocidal products guide covers that route.

How the Commission’s working group applies this to claims, in its own examples:

The hand gel document is a working document of the Sub-Working Group on Borderline Products, dated 12 November 2020. It says that claims, which it defines as text, names, trade marks, pictures and figurative or other signs, “can, nevertheless, be a strong indication of the main purpose of a product”. It deals with biocidal claims and leaves medicinal claims aside.

Environmental claims on a cosmetic

Directive (EU) 2024/825Directive (EU) 2024/825, Empowering Consumers for the Green TransitionThe whole regulationClick opens the law on the EU Publications Office. amended Annex I to the Unfair Commercial Practices Directive, the list of practices banned in all circumstances. EU countries had to apply their national measures from 27 September 2026 (Art. 4(1)Directive (EU) 2024/825, Empowering Consumers for the Green TransitionThe whole regulationClick opens the law on the EU Publications Office. of Directive (EU) 2024/825Directive (EU) 2024/825, Empowering Consumers for the Green TransitionThe whole regulationClick opens the law on the EU Publications Office.), so the bans below are in force now. A cosmetic claim such as “eco-friendly” is a commercial practice like any other and meets these bans as well as the six criteria. The Directive reaches each EU country through its own national law. This guide did not check how each country transposed it. The general rules on green claims are on their own page.

Recital 10 of the Directive says recognised excellent environmental performance can be shown by compliance with the EU Ecolabel (Regulation (EC) No 66/2010Regulation (EC) No 66/2010, EU Ecolabel (consolidated text of 14 November 2017)The whole regulationClick opens the law on the EU Publications Office.), by an officially recognised EN ISO 14024 ecolabelling scheme of an EU country, or by top environmental performance under other Union law, such as class A under Regulation (EU) 2017/1369Regulation (EU) 2017/1369, Energy Labelling Regulation (consolidated text of 1 May 2021)The whole regulationClick opens the law on the EU Publications Office.. It must be relevant to the entire claim. The Ecolabel, for one, does not support “biodegradable” where the criteria for the product set no requirement on biodegradability. The third column is this guide’s reading of how the points apply to a cosmetic, not the Directive’s own text.

Who owes what

What happens if you do nothing

A claim that breaks Art. 20Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 20Click opens the article on EUR-Lex. is a ground on which the authority requires the responsible person to take all appropriate measures: bring the product into conformity, withdraw it or recall it, within an expressly set time limit (Art. 25(1)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 25, paragraph 1Click opens the article on EUR-Lex., point (i)). The responsible person ensures the measures reach all the products concerned on the EU market (Art. 25(3)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 25, paragraph 3Click opens the article on EUR-Lex.). Where it does not act in time, or the risk is serious, the authority itself prohibits, restricts, withdraws or recalls the product (Art. 25(5)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 25, paragraph 5Click opens the article on EUR-Lex.). A distributor faces the same demands for its own duties (Art. 26Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 26Click opens the article on EUR-Lex.). Each EU country sets the penalties, which must be effective, proportionate and dissuasive (Art. 37Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 37Click opens the article on EUR-Lex.).

If the authority decides that a claim makes the product a medicine, the cosmetic route closes: no medicinal product may be placed on the market without a marketing authorisation (Art. 6(1) of Directive 2001/83/EC). If it decides the product is a biocidal product, it may not be made available unless authorised, apart from the national transition rule of Art. 89(2) set out in the biocidal products guide (Art. 17(1)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 17, paragraph 1Click opens the article on EUR-Lex., Art. 89(2)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 89, paragraph 2Click opens the article on EUR-Lex.). If it decides the product is a medical device, the medical device rules apply; the Borderline manual puts products that heal or treat wounds between medicinal products and medical devices, to be settled case by case (paragraph 185). See the medical device guide.

What is proposed but not yet law

On 8 July 2025 the Commission proposed amending the Cosmetics Regulation (COM(2025) 531). Its amendments to Regulation (EC) No 1223/2009Regulation (EC) No 1223/2009, Cosmetic Products RegulationThe whole regulationClick opens the law on the EU Publications Office. cover a new Article 14a, Articles 15, 16, 19(6), 22 and 33, and the Annexes. It does not change Art. 20Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 20Click opens the article on EUR-Lex. or Art. 11Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 11Click opens the article on EUR-Lex., and it does not mention Regulation 655/2013. The latest consolidated text of the Cosmetics Regulation on 5 October 2026 is that of 18 May 2026, and it carries none of these changes.

What the law leaves open

• The words “natural”, “organic”, “vegan” and “clean”. Neither the Cosmetics Regulation nor Regulation 655/2013 defines them, and the criteria set no wording (Recital 7). Directive (EU) 2024/825Directive (EU) 2024/825, Empowering Consumers for the Green TransitionThe whole regulationClick opens the law on the EU Publications Office. does not list them either, but it bans a generic environmental claim without recognised excellent environmental performance (see the section on environmental claims), and whether a word like “natural” or “clean” counts as one depends on whether it suggests environmental performance. No official guidance for cosmetics settles that. Meanwhile: treat each as any other claim. It has to be true of the finished product (criterion 2), backed by evidence (criterion 3) and not denigrate other products or legal ingredients (criterion 5). Do not use it to suggest environmental performance you cannot show.
• How firm the technical document is. It is guidance of 2017 that calls itself a work in progress, and no article makes its examples binding. National authorities and courts decide claims case by case. Meanwhile: follow its examples; they are what an assessor holds a claim against.
• Where “disease” begins. The Borderline manual notes that a Community definition of “disease” does not exist, and that a reference to a sensation such as itching “is not decisive” on its own (paragraphs 95 and 96). The same word can end up on either side of the line, product by product. Meanwhile: word a claim around the cosmetic function and leave out the treatment of a condition.
• The language of a claim. Art. 19(5)Regulation (EC) No 1223/2009, Cosmetic Products RegulationArticle 19, paragraph 5Click opens the article on EUR-Lex. lets each EU country set the language of the content, durability, precautions and function, and no article of the Regulation or of Regulation 655/2013 names a language for a claim. The criteria ask that a claim is understood by the average end user, taking linguistic factors into account (Annex, points 1(2) and 6(1)). Meanwhile: write the claim in the language of the country where the buyer is.

What you can skip